QA Digital Compliance Manager
We couldn't confirm this posting on AbbVie's site in our latest checks -- see current similar openings below.
About this opportunity
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Job Description
The QA Digital Compliance Manager is responsible for ensuring that all digital systems, records, instruments, processes and data handling within operations adhere to relevant regulatory, legal, best practices and industry standards.
Key Responsibilities:
Monitoring and ensuring adherence to relevant regulatory bodies (e.g. FDA, EMA) for digital content and initiatives in compliance with regulations like FDA 21 CFR Part 11 and EU Annex 11. Keeping updating with evolving digital compliance regulations and trends (eg Annex 22 about AI).
Ensuring and maintaining Quality oversight of data integrity and traceability across computerized systems lifecycle such as manufacturing execution system, and laboratory information management systems (LIMS), electronic lab notebooks (ELN/LES), and instrument software.
Support the implementation of proper cybersecurity measures to protect data and prevent unauthorized access or tampering.
Supporting as Subject Matter Expert the training to employees and stakeholders on digital compliance requirements and best practices and the audit of digital systems and assure the adherence to GMP, company policies and other relevant standards, including risk assessments, Supplier qualification and periodic System Audit Trail reviews.
Ensuring software and digital tools and systems used in operations are validated and documented according to regulatory and company requirements through the review and approval of validation documents
Supporting the development, review, and update of digital compliance policies and procedures.
Collaborating with Global and Local IT, BTS and all relevant functions to maintain compliant digital strategies.
Investigating and responding to non-compliance events. Contributing to change management and lifecycle handling.
Qualifications
Bachelor’s degree in Life Sciences, IT or related field; master’s degree preferred.
5/10+ years of experience in digital compliance applied in pharmaceutical industry
Strong knowledge of pharmaceutical regulations (FDA, EMA, etc.)
Excellent communication and training skills.
Fluent English language
Analytical mindset and attention to detail.
Experience in managerial roles in complex organizations.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 238 comparable Manager Quality roles across 73 biopharma companies.
Salary context
56 of 238 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 238 comparable roles
+ 23 more countries
Seniority mix
238 of 238 peers have a known seniority level
Therapeutic area mix
0 of 238 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
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How we calculate "similar"
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.